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Results of Phase III HARMONY trial of pimavanserin for dementia-related psychosis have been published in the New England Journal of Medicine

Thursday 22 July 2021

On 22 July, a team of researchers published the results of the HARMONY Phase III clinical trial, in the New England Journal of Medicine. The Phase III HARMONY trial was a double-blind, randomised and placebo-controlled study designed to evaluate the efficacy of pimavanserin in treating dementia-related psychosis. The trial enrolled 392 participants with dementia (i.e. vascular, frontotemporal or Alzheimer’s disease dementia, dementia with Lewy bodies or dementia associated with PD) having previously experienced dementia-related psychosis.

During the initial 12-week open-label treatment period, 217 of 351 patients (61.8%) had a sustained reduction in psychosis symptoms, of whom 105 were assigned to receive pimavanserin and 112 to receive placebo. A relapse occurred in 12 of 95 patients (13%) in the pimavanserin group and in 28 of 99 (28%) in the placebo group. The study met its primary endpoint of delaying relapse of psychosis compared to placebo and was stopped for efficacy at the pre-planned interim analysis. Participants with dementia-related psychosis who had a response to pimavanserin had a lower risk of relapse then the placebo group. Common adverse events that occurred were headacheconstipation, and urinary tract infection.

https://www.nejm.org/doi/full/10.1056/NEJMoa2034634

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